Is This The Next Big Thing in Boob Jobs?

If you're going in for a breast augmentation, chances are you're going to get silicone-gel implants. That's because as a rule, silicone feels softer and, therefore, more natural than saline, the other option. Saline implants also have a tendency to slosh around when a woman changes position, and the shell can wrinkle and fold. So it's no surprise that of the nearly 287,000 augmentation procedures performed last year, 80 percent involved silicone. But now the makers of the Ideal Implant, a new kind of saline implant that is being introduced this week, hope to change all that. It may be an uphill battle.

Innovation in saline implants is unusual. Since silicone gel was approved by the FDA in 2006, there have been numerous innovations in the shape and cohesiveness of these implants. While there have been a handful of design patents filed for saline implants, the Ideal is the first new saline design to be cleared by the FDA in 20 years. (It was approved last year but is just becoming available this week.)

Women who opt for saline like the idea of a "natural" substance and may fear silicone, despite the fact that numerous studies have ruled out a link between silicone-gel-filled implants and cancer or autoimmune diseases. Additionally, the incision and scar can be shorter with a saline implant, since the implant can be placed through an underarm incision, or around the nipple, and then inflated. Saline is also cheaper; it costs as much as $1,000 less.

But perhaps the biggest difference between saline and silicone-gel implants is the fear of the "silent rupture." When a silicone-gel implant tears for a variety of reasons, it is often hard to detect. For that reason, the FDA recommends that patients with silicone-gel implants have an MRI three years after the initial augmentation and every two years after that, something patients find difficult and expensive to comply with. (According to a 2014 National Institute of Health analysis, "silent rupture" occurred in 9 to 12 percent of cases eight years postimplantation. However, a study of the the newest generation of cohesive-gel implants, which are firmer and don't run if torn, reported lower rupture rates, only 1.1 percent at six years postimplantation for first-time patients.)

In contrast, if a saline implant ruptures, a woman can usually feel it right away, says Bonnie Baldwin, a plastic surgeon in Houston. "If it deflates, you know it immediately. Women who choose saline want the peace of mind of knowing they don't need a mammogram if it ruptures. And there are still women here who are concerned about silicone even though it has been proved to be safe if there is a rupture.”

The Ideal is the brainchild of Robert Hamas, a past president of the Dallas Society of Plastic Surgeons. "I began to realize how much women were bothered by not knowing the status of their implants. Were they intact or silently ruptured? It is really an emotional issue for women. I felt there had to be a better type of breast implant," he says.

First Hamas had to solve the problem that saline implants can feel like a water balloon on your chest. His lightbulb moment came in 1992, when he experienced turbulence on a flight. "The ice in my drink kept it from sloshing, so it made me think of putting something inside a saline implant to keep it from sloshing," he says. After getting no support from existing implant companies, Hamas decided to develop the idea himself. With the help of two engineers, numerous consultants, investments from fellow surgeons, and years of trial and error, he settled on perforated free-floating baffles made of the same material as the silicone shell. (The larger the implant, the more baffles.) "They stay in place between the inner and outer shell without attachment because they have the same shape and exactly the same proportions as the shells," says Hamas. "Like nesting Russian dolls."

A ten-year study of the Ideal, conducted by the company, is currently under way at 35 sites in seven metropolitan areas. It will conclude in 2019 and includes almost 500 women, ages 18 to 67. FDA approval was based on the initial two-year results. Capsular contracture rates (the unpredictable hardening of the shell that forms around implants, which can occur with both silicone and saline implants and increase with time) was lower at four years in first-time Ideal Implant patients (5.4 percent) than with other saline implants at three years (8.7 and 9.0 percent) or silicone gel implants.

Still, saline implants concern Steven Teitelbaum, an associate clinical professor of plastic surgery at the David Geffen School of Medicine at UCLA. He has extensive experience with silicone-gel implants and has done research on implants made by the other three approved manufacturers. "Saline is noncompressible and can't be squished,'" he wrote to me in an email. "This new implant is soft only because it is underfilled,' which gives the saline room to move around in the shell, but this means that it can collapse and fold over at the top, shortening its height and losing upper fill, and that fold might be seen or felt, and such folds can lead to leakage over time."

Hamas readily admits that "problems with the first batch of implants used in the trial led to a high percentage of deflations at four years in first-time augmentation patients [9.8 percent]." To rectify the problem, Ideal changed its manufacturer and addressed inspection issues.

Baldwin, who participated in the Ideal trial but has no financial interest in the venture, says her five patients in the trial are all pleased. "Three are very thin, a true test for wrinkling because there's not a lot of tissue to cover the implant," she says. "It looks natural even in a thin person, and when she lies down she won't have a pancake. It won't go flat. It will lateralize a little but still look, how shall I say it...perky."

Many implant specialists are taking a wait-and-see attitude. "Plastic surgeons will always welcome the development of new breast implants because none manufactured to date have proven to be 'ideal' over the long term," says David Hidalgo, a Manhattan plastic surgeon and clinical professor of surgery at Weill-Cornell Medical College, who has extensive experience with breast implants. "The new Ideal Implant is a complex design, which for the first time includes moving parts and two fill ports. Whether or not this design is both durable and a superior aesthetic alternative remains to be proven."